510(k) · Cleared
ClearedB-Scan Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accutome Ultrasound, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 19, 2007 as substantially equivalent to K960765 (Mentor Ophthalmics, Inc., 1996) after a 15-day review. Its family tree reaches back 2 generations to 1987. 3 later devices descend from it.
- Decided
- Apr 19, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871536 (1987). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK871536 Ophthasonic a-Scan/ B-ScanTeknar, Inc. · 1987
- 1 generation backK960765 Mentor Advent a/B SystemMentor Ophthalmics, Inc. · 1996
- This deviceK070943 B-Scan PlusAccutome Ultrasound, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK243227 B-ScanAccutome, Inc. Doing Business AS Keeler USA · 2025
- Descendant · cites it directly · 0 of its ownK152573 4SightAccutome, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK103471 Ubm PlusAccutome, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871536 | Ophthasonic a-Scan/ B-Scan | Teknar, Inc. | 1987 | — |
| −1 | K960765 | Mentor Advent a/B System | Mentor Ophthalmics, Inc. | 1996 | — |
| 0 (this device) | K070943 | B-Scan Plus | Accutome Ultrasound, Inc. | 2007 | — |
| +1 | K243227 | B-Scan | Accutome, Inc. Doing Business AS Keeler USA | 2025 | — |
| +1 | K152573 | 4Sight | Accutome, Inc. | 2015 | — |
| +1 | K103471 | Ubm Plus | Accutome, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960765 | Mentor Advent a/B SystemSummary page 1…System, Imaging, Pulsed Echo, Ultrasonic (see: 21 CFR 892.1560) Product Code: IYO Panel: 90 Legally Marketed Advent A/B System (K960765) Predicate Devices: Description of the Device: The B-Scan Plus device is designed as an ultrasound B-… | 1996 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243227 (Accutome, Inc. Doing Business AS Keeler USA, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K960765.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The instrument is used for imaging the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070943: B-Scan Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070943
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026